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Biom J. 2009 Apr;51(2):348-57. doi: 10.1002/bimj.200800266.

Sample size re-estimation in clinical trials.

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  • 1National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892-7609, USA.


Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid-stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re-estimation when the outcome is continuous.

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